UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020148 |
|---|---|
| Receipt number | R000020662 |
| Scientific Title | Effect of Aroma hand massage on the improvement of cognitive function |
| Date of disclosure of the study information | 2015/12/10 |
| Last modified on | 2015/12/16 10:56:17 |
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Basic information
Public title
Effect of Aroma hand massage on the improvement of cognitive function
Acronym
Effect of Aroma hand massage on the improvement of cognitive function
Scientific Title
Effect of Aroma hand massage on the improvement of cognitive function
Scientific Title:Acronym
Effect of Aroma hand massage on the improvement of cognitive function
Region
| Japan |
Condition
Condition
decline of cognitive function, MCI, dementia
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of Aroma hand massage on cognitive function
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive function
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom | Maneuver | Other |
Interventions/Control_1
first examination --> Aroma hand massage for 10 minutes before sleeping at home for 6 weeks --> second examination --> Live as usual -->final examination
Interventions/Control_2
first examination --> Live as usual --> second examination --> Aroma hand massage for 10 minutes before sleeping at home for 6 weeks -->final examination
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Those who live around matsuyama or Toon, Ehime Japan
2. Those who can participate in the trial in pairs of couple or friends (those who receice aroma hand massage need to be more than 65 years old)
3. Those who can give aroma hand massage to the other every day.
4. Those who can come to the examination for themselves.
5. Those who are interested in preventing dimentia or improving cognitive function
6. After enough explanation of the trial, those who agree with participation and give written informed concent.
Key exclusion criteria
1. Those who have sivere heart disease
2. Those who have sivere hipertension
(180/110 mmHg or more)
3. Those who have sivere arrhythmia
4. Those who are pregnant
5. Those who have other sivere disease
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiki Ogino |
Organization
Okayama University Graduate School of Medicine, Dentistry, and Phermaceutical Sciences
Division name
Public Health
Zip code
Address
2-5-1, Shikata, Kitaku, Okayama, Japan
TEL
086-235-7184
kogino@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eri Eguchi |
Organization
Okayama University Graduate School of Medicine, Dentistry, and Phermaceutical Sciences
Division name
Public Health
Zip code
Address
2-5-1, Shikata, Kitaku, Okayama, Japan
TEL
086-235-7184
Homepage URL
eri_eguchi@okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry, and Phermaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
Health Labour Sciences Research Grant,
Comprehensive Research on Life-Style Related Diseases
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2015 | Year | 07 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 21 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 10 | Day |
Last modified on
| 2015 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020662
